How you can help us grow End­points News through the pan­dem­ic

We’re lucky at End­points News.

Read­er en­gage­ment is the high­est we’ve ever seen as we ap­proach 80,000 dai­ly email sub­scribers — with over 20% of them un­der a paid plan. Busi­ness op­er­a­tions are strong, with our team of 17 de­ployed at home of­fices across the US, Eu­rope, and Asia be­fore it be­came manda­to­ry. And we can sell ad­ver­tis­ing to clients who need to reach a hy­per-fo­cused au­di­ence. It’s a way of reach­ing out, with­out touch­ing, that has be­come in­creas­ing­ly trendy. The vir­tu­al na­ture of our busi­ness gives us a few crit­i­cal ad­van­tages in re­spond­ing to the cri­sis.

There are chal­lenges, of course.

Live events ac­count for a third of our rev­enues — or used to, at least. Con­nect­ing the bio­phar­ma world is a vi­tal part of our mis­sion, and there’s no re­al sub­sti­tute for mak­ing new per­son­al con­nec­tions at con­fer­ences.

So un­til we’re able to meet in close quar­ters again — stretch­ing well in­to 2021 — all End­points events will be vir­tu­al. We’re start­ing with an ag­gres­sive slate of vir­tu­al Zoom pan­els fea­tur­ing the in­dus­try’s top lead­ers. We’ll have more on that soon. And the team is look­ing at new and in­no­v­a­tive ways at de­liv­er­ing these events, be­yond the stan­dard video pan­els. There’s a huge op­por­tu­ni­ty to reimag­ine on­line con­fer­ences and the val­ue they bring to both at­ten­dees and spon­sors.

To be sure, the bio­phar­ma in­dus­try it­self is demon­strat­ing some re­al re­silience in the cri­sis. That’s im­por­tant. Bio­phar­ma will be back, al­tered — cer­tain­ly — but more fo­cused on big things than ever be­fore.

We’re look­ing for­ward to writ­ing about that.

While we’ve been fo­cused on cov­er­ing the out­break and its im­pact on the in­dus­try — our spe­cial niche — we’ve put few­er sto­ries be­hind the pay­wall. That will change soon, and we need your sup­port now more than ever.

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For those of you who have a paid sub, thank you. For those of you get­ting one to­day, be sure that we have nev­er been more ap­pre­cia­tive of your sup­port for the in­de­pen­dent mis­sion we have carved out for our­selves as we boot­strapped this start­up.

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Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.

Take­da earns win for its TKI in­hibitor in tiny lung can­cer group — but GI side ef­fects could be an ear­ly red flag

Japanese drugmaker Takeda has made a big push in recent years to build a hand in oncology, particularly in the next-gen cancer space. One of those candidates, tyrosine kinase inhibitor (TKI) mobocertinib, recently earned the FDA’s interest in a small section of untreated lung cancer patients, but will severe GI side effects be a roadblock?

Takeda’s oral mobocertinib posted clinically significant objective response rates in a Phase I/II adaptive trial drugging metastatic non-small cell lung cancer patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, according to data presented Thursday at the virtual World Conference on Lung Cancer.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Covid-19 roundup: Con­tro­ver­sy around colchicine per­co­lates af­ter study fail­ure; As­traZeneca's meet­ing with EU was 'con­struc­tive,' but did­n't solve much

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

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'Bank of BAR­DA': In­ves­ti­ga­tion finds HHS raid­ed pan­dem­ic pre­pared­ness funds for decade be­fore Covid-19

Before 2020, few Americans had ever heard of the Biomedical Advanced Research and Development Authority, BARDA, or its far-flung mission to stave off future pandemics and bio-threats. Allegedly, that made it a pretty good target for others in HHS who needed to scavenge some extra cash.

Over the last decade, other HHS officials raided BARDA’s coffers and misappropriated millions of dollars that Congress had earmarked to fund vaccine research and prepare for public health emergencies like Covid-19, according to a new report from the US Office of Special Counsel, which investigated a whistleblower report.